Download or read book Pharmaceutical Quality Systems written by Oliver Schmidt and published by CRC Press. This book was released on 2000-04-30 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr

Download or read book Laboratory Quality Management System written by World Health Organization and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".

Download or read book Standards Quality Control and Measurement Sciences in 3D Printing and Additive Manufacturing written by Chee Kai Chua and published by Academic Press. This book was released on 2017-06-03 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: Standards, Quality Control and Measurement Sciences in 3D Printing and Additive Manufacturing addresses the critical elements of the standards and measurement sciences in 3D printing to help readers design and create safe, reliable products of high quality. With 3D printing revolutionizing the process of manufacturing in a wide range of products, the book takes key features into account, such as design and fabrication and the current state and future potentials and opportunities in the field. In addition, the book provides an in-depth analysis on the importance of standards and measurement sciences. With self-test exercises at the end of each chapter, readers can improve their ability to take up challenges and become proficient in a number of topics related to 3D printing, including software usage, materials specification and benchmarking. Helps the reader understand the quality framework tailored for 3D printing processes Explains data format and process control in 3D printing Provides an overview of different materials and characterization methods Covers benchmarking and metrology for 3D printing

Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by World Health Organization. This book was released on 2007 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.

Download or read book Guide to Preparing the Corporate Quality Manual written by Bernard Froman and published by CRC Press. This book was released on 2020-11-25 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: Utilizes advanced concepts, guidelines and requirements from the latest ISO 9000 and 10000 series of standards, as well as other models, including TQM (Total Quality Managment). The text shows how to define a policy and explain it clearly. It offers procedures for developing a quality manual, to be used by personnel performing quality-related functions and for external auditors and customers.

Download or read book Quality Management Systems for the Food Industry A Guide to ISO 9001 2 written by A. Bolton and published by Springer Science & Business Media. This book was released on 1997-07-31 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ISO 9001/2 series of standards for Quality Management Systems is of increasing importance to the food and drink industry; it functions as an outward and visible sign to customers that the industry has a defined quality management system that has been independently appraised and is regularly audited. ISO 9001/2 certification can enable a company, to reduce the audit burden from a multitude of customers and can also help the manufacturer or distributor involved in auditing its own suppliers. Above all, it may improve the effectiveness of its own operation and profits. Quality Management Systems for the Food Industry describes what the standards are, what they mean and how to achieve them, and identifies both the potential benefits and limitations. It discusses choice of assessment house, whether to use consultants or not, and particularly points out the detail that assessors will be looking for. Guidance is given on the basic format for a suitable quality management system.

Download or read book Achieving Customer Experience Excellence through a Quality Management System written by Alka Jarvis and published by Quality Press. This book was released on 2016-07-08 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: We are in what many call “The Age of the Customer.” Customers are empowered more than ever before and demand a high level of customer attention and service. Their increasing expectations and demands worldwide have forced organizations to transform themselves and prepare for the customer experience (CX) battlefield. This landmark book addresses: What customer experience really means Why it matters Whether it has any substantial business impact What your organization can do to deliver and sustain your CX efforts, and How we got to this particular point in CX history This book is the result of exhaustive research conducted to incorporate various components that affect customer experience. Based on the research results, the authors make a case for seeing CX and associated transformations as the next natural evolution of the quality management system (QMS) already in place in most companies. Using an existing QMS as the foundation for CX not only creates a more sustainable platform, but it allows for a faster and more cost effective way to enable an organization to attain world-class CX.

Download or read book Quality Management written by Marco Sartor and published by Emerald Group Publishing. This book was released on 2019-05-09 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book describes the most important quality management tools (e.g. QFD, Kano model), methods (e.g. FMEA, Six Sig-ma) and standards (e.g. IS0 9001, ISO 14001, ISO 27001, ISO 45001, SA8000). It reflects recent developments in the field. It is considered a must-read for students, academics, and practitioners.

Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Download or read book Quality Management and Quality Assurance Standards written by International Organization for Standardization and published by Rexdale, Ont. : Canadian Standards Association. This book was released on 1993 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Quality systems Part 1 Quality management and quality system elements guidelines written by Standards Association of New Zealand and published by . This book was released on 1990 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Download or read book Guidelines for Integrating Management Systems and Metrics to Improve Process Safety Performance written by CCPS (Center for Chemical Process Safety) and published by John Wiley & Sons. This book was released on 2016-02-23 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book combines the synergies between performance improvement systems to help ensure safe and reliable operations, streamline procedures and cross-system auditing, and supporting regulatory and corporate compliance requirements. Many metrics are common to more than one area, such that a well-designed and implemented integrated management system will reduce the load on the Process Safety, SHE, Security and Quality groups, and improve manufacturing efficiency and customer satisfaction. Systems to improve performance include: process safety; traditional safety, health and environment; and, product quality. Chapters include: Integrating Framework; Securing Support & Preparing for Implementation; Establishing Common Risk Management Systems – How to Integrate PSM into Other EH; Testing Implementation Approach; Developing and Agreeing on Metrics; Management Review; Tracking Integration Progress and Measuring Performance; Continuous Improvement; Communication of Results to Different Stakeholders; Case Studies; and Examples for Industry.

Download or read book Clinical Practice Guidelines We Can Trust written by Institute of Medicine and published by National Academies Press. This book was released on 2011-06-16 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

Download or read book Understanding ISO 9000 and Implementing the Basics to Quality written by D.H. Stamatis and published by CRC Press. This book was released on 1995-08-08 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work examines the evolution and rationale of the ISO 9000 series of standards, their structure, interpretation and relationship to other quality systems. Theory and applications are provided, and the author explains how to put the standards into place and achieve quality. Specific methods and tools for the implementation of the ISO standards that lead to certification and certification maintenance are supplied.

Download or read book Guidance for Preparing Standard Operating Procedures SOPs written by and published by . This book was released on 2001 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book ISO 9001 2015 Explained written by Charles A. Cianfrani and published by Quality Press. This book was released on 2015-09-21 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2015 edition of ISO 9001 has been modernized to update terminology and content to meet current and anticipated user needs. The major emphasis of ISO 9001:2015 is still consistent provision of products and services that meet customer and applicable statutory and regulatory requirements. This book explains the meaning and intent of the requirements of ISO 9001:2015 and discusses the requirements as they relate to each of the product categories. Where appropriate, it includes an elaboration of why the requirements are important. It also includes typical audit-type questions that an organization may consider to assess conformity to internal needs and ISO 9001 requirements. Recommendations for implementation are also included. This book addresses the needs of: Users and organizations seeking a general understanding of the contents of ISO 9001:2015 Users and organizations desiring guidance to ensure their ISO 9001:2015 QMS meets the new version requirements Users and organizations considering the use of ISO 9001:2015 as a foundation for the development of a comprehensive QMS Educators who require a textbook to accompany a training class or course on ISO 9001:2015 Auditors who desire to increase their level of auditing competence Authors Cianfrani and West, members of the expert group that developed ISO 9001:2015, strive to provide a context for all requirements to enable you to develop and deploy processes that will strengthen your QMS. Getting or retaining a certificate is not the real objective. Satisfied customers and organizational sustainability should be primary objectives for the organization.